Surgical procedures generally involve the use of some type of surgical drape or incise material. The purpose of these surgical drapes or incise materials is to maintain the area of the incision through the skin in as clean and sterile fashion as possible. Generally, in performing a surgical procedure, the planned incision area is cleaned, the area is treated with an antiseptic agent, an adhesively backed sterile incise drape is applied to the tissue, and sterile towels are applied around the target area to drape the target surgical site. The sterile towels are applied in a pattern to form a fenestration or window around the area of the planned incision within which the surgical procedure is performed. Following the procedure, the wound is often closed with a plurality of sutures or staples, and a wound dressing is applied. Therefore, surgical procedures often utilize several medical devices to prepare and shield the incisional site, to close the wound and protect the incision during healing.
1. Field of Invention
The present invention is related to a surgical wound closure device that is multi-functional, and that provides medical practitioners with a device that protects the incision from contamination pre-surgically, prevents accidental contamination peri-operatively, enables alignment and approximation of the edges of the incision during closure, serves as the primary means of closure of the incision, and serves as a protective wound dressing post surgically.
2. Description of Related Art
Multi-functional medical devices performing two or three functions selected from a sterile surgical drape, an incision approximation device, a wound closure device and a sterile dressing, have been described in the prior art. For example, U.S. Pat. No. 4,899,762 discloses a combination surgical drape, dressing and closure device, which includes a combination drape/dressing having a central dressing portion, which may have an incision guide line, and peripheral drape portions which are secured together with a weakened tear line. This reference also teaches a straddling closure that is utilized in conjunction with the combination drape/dressing which may be integral or separate from the combination drape/dressing.
Additionally, U.S. Pat. Nos. 4,222,383 and 4,976,726 describe multi-functional devices that may perform the dual functions of a surgical drape and wound closure device. U.S. Pat. Nos. 4,114,624 and 4,531,521 describe surgical wound devices that perform the dual functions of being a template for incision and a wound closure device. U.S. Pat. No. 6,007,564 discloses the use of several devices to perform (i) the dual functions of being a drape and a dressing, and (ii) a wound closure device.
However, there are disadvantages associated with the devices described in the prior art. For example, as shown in FIGS. 6-8 of U.S. Pat. No. 4,899,762, this reference teaches a multiple layer dressing that comprises two adhesive layers and two substrates over the incision after completion of the surgical procedure. This multiple layer structure remaining over the incision severely impedes the transmission of water vapor from the skin tissue and increases the chance of skin maceration. U.S. Pat. No. 4,222,383 does not perform the functions of an incision approximation device and a dressing. U.S. Pat. Nos. 4,114,624 and 4,531,521 describes devices that limit the type of incision that may be made by a physician and require the device to be placed with some degree of accuracy over the targeted incision site since the device functions as an incision template. Moreover, these devices require the physician to place two separate portions of the wound closure device on either side of the incision in such a manner that the patient's skin is not actually supported by the device. Additionally, since the incision is made in a pre-existing gap between the two separate portions of the wound closure device, flora in the surrounding tissue may enter the incision as the incision is made. The disadvantage associated with U.S. Pat. No. 4,976,726 is that the sheet that may function as a drape is not removed from the incision site after the surgical procedure and the closure means is placed directly upon a contaminated surface. In addition, a multiple layer structure remains over the incision after the surgical procedure, which severely impedes the transmission of water vapor from the skin tissue and increases the chance of skin maceration. U.S. Pat. No. 6,007,564 requires the use of multiple devices to perform the various functions.
While these previous disclosures teach multi-functional surgical devices, there is still a need for a multi-functional device that is simple to use and that performs additional functions. Specifically, it is desirable to have a surgical wound closure device without the disadvantages described above, that performs the functions of a sterile surgical drape, an incision approximation device, a closure device and a sterile dressing, and that does not significantly impede the natural water vapor transmission of the skin tissue.